achieve compliance, reduce risk, enhance safety

Rapid eDHR Solution

Jump-start your electronic record-keeping and begin to see advantages at your next 21-CFR Part 11 compliance audit.
Values & Capabilities

Delivered by Manufacturing Experts


Cloud-Based Technology

Servers, data storage devices, networking equipment, and software are all leveraged within a powerful, streamlined cloud environment.

Subscription-based Pricing

Our pricing model is based on usage.

Rapid Implementation

90 day Proof of Concept (POC) offering - quick implementation is part o f our DNA.

Flexible Configuration

Ability to configure our platform to our customers' specific needs and industry.

Multi-Plant Visibility

42Q provides global visibility of production, accessible anywhere in the world with real-time analytics updates & comprehensive dashboards.

Track & Trace Genealogy

42Q provides the ultimate unit history record solution, tracking all components, product changes, repairs and upgrades.
Module Options

Electronic Device History Record (eDHR)

An electronic device history record (eDHR) allows manufacturers to collect and manage critical records required by the FDA to document the production of each device. By automating your device history record processes with an eDHR, you can more confidently achieve compliance with FDA cGMP requirements, reduce risk, and enhanced safety for medical device users. By bringing together all data about a device’s manufacturing and testing history, the eDHR tracks data to ensure the document process and compliance was followed. That includes the requirement that the components and materials approved for assembly into the product were the ones actually used, all tests passed, and that all workers involved in the manufacturing and testing processes were trained and certified on the required operations.

The Fastest, Easiest Way to Launch eDHR Quality Records

With the Rapid eDHR solution, you can jump-start your electronic record-keeping and begin to see advantages at your next compliance audit. The Rapid eDHR offering is part of the 42Q Cloud platform: a complete, scalable Cloud solution for managing global manufacturing operations.

eDHR Includes:

• Tracking and Traceability

• Online Work Instructions

• Employee Verification

• 42Q Live and Operations Dashboard

• Standard Reports & Cycle Time Report

Our Customers Deploy in as Little as 6 Weeks

Our deployment services team is certified in our RPM (Rapid Production Model) implementation methodology and will guide you through a timely and effective deployment of 42Q.

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